CONTRAINDICATIONS / PRECAUTIONS

Closed-angle glaucoma

Naphazoline causes vasoconstriction of conjunctival blood vessels, which may exacerbate the effects of glaucoma; thus, use of the prescription strength ophthalmic solution (i.e., naphazoline 0.1%) is contraindicated in patients with closed-angle glaucoma. Some over-the-counter ophthalmic solutions also contain naphazoline; however, they are formulated with a lower drug concentration (i.e., naphazoline 0.03% or less). Glaucoma patients should use these OTC products only after receiving approval from their prescriber.

MAOI therapy

Naphazoline should be used cautiously in patients receiving MAOI therapy as the combination of an MAOI and a sympathomimetic drug may result in hypertensive crisis.

Children, infants, neonates

The safety and efficacy of naphazoline ophthalmic solution have not been established in neonates, infants, children, and adolescents. Use in pediatric patients, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.

Contact lenses

Instruct patients to removed contact lenses prior to ophthalmic administration of naphazoline. The inactive preservative, benzalkonium chloride, may be absorbed to the surface of soft contact lenses.

Cardiac disease, hypertension

Naphazoline should be used with caution in patients with hypertension or cardiac disease as systemic absorption of the drug may result in increased blood pressure and cardiac irregularities.

Hyperthyroidism

Naphazoline should be used with caution in thyroid disease patients with hyperthyroidism, because they can be more sensitive to catecholamines.

Diabetes mellitus

Naphazoline should be used with caution in patients with diabetes mellitus as systemic absorption of the drug may result in hyperglycemia.

Ocular infection, ocular trauma

Use naphazoline ophthalmic solution with caution in the presence of ocular infection or ocular trauma.

Pregnancy

Naphazoline is classified as FDA pregnancy category C. It is not known if the drug can cause fetal harm when administered to a pregnant woman. Limited data have not demonstrated a clinically significant effect on the fetus during first trimester exposure of naphazoline; however, other sympathomimetic drugs have been associated with minor malformations, inguinal hernia, and clubfoot. According to the manufacturer, naphazoline should be given to a pregnant woman only if clearly needed.

Breast-feeding

According to the manufacturer, it is not known whether naphazoline is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

DRUG INTERACTIONS

There are no drug interactions associated with Naphazoline products.

PREGNANCY AND LACTATION

Pregnancy

Naphazoline is classified as FDA pregnancy category C. It is not known if the drug can cause fetal harm when administered to a pregnant woman. Limited data have not demonstrated a clinically significant effect on the fetus during first trimester exposure of naphazoline; however, other sympathomimetic drugs have been associated with minor malformations, inguinal hernia, and clubfoot. According to the manufacturer, naphazoline should be given to a pregnant woman only if clearly needed.

According to the manufacturer, it is not known whether naphazoline is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

US-based MDs, DOs, NPs and PAs in full-time patient practice can register for free on PDR.net. PDR.net is to be used only as a reference aid. It is not intended to be a substitute for the exercise of professional judgment. You should confirm the information on the PDR.net site through independent sources and seek other professional guidance in all treatment and diagnosis decisions.